Safe Anastomosis Feasibility Study

NCT ID: NCT05180565

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2022-03-31

Brief Summary

A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer

Detailed Description

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

Colovac+ is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Conditions

Colorectal Cancer; Anastomosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colovac

Patients receive Colovac device during colorectal surgery

Group Type: EXPERIMENTAL

Colovac

Intervention Type: DEVICE

A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)

Interventions

Colovac

A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (18 years of age or older)
• Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
• Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria

• Preoperatively :

1. Patient with inflammatory bowel disease

2. Known allergy to nickel or other components of the Colovac+ kit

3. Pregnant or nursing female subject

4. Concomitant major surgical procedure in combination with Colorectal resection (i.e. hepatectomy)

5. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:

1. COVID-19 positive (active infection) based on test within 72 hours prior to surgery

2. Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1

3. Immunodeficiency (CD4+ count < 500 CU MM)

4. Systemic steroid therapy within the past 6 months

5. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery

6. Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study

7. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis

8. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging

9. Severe Malnutrition defined as 10% weight loss within 3 months prior to enrollment.

6. The subject is currently participating in another investigational drug or device study

• Intraoperatively :

7. Anastomosis placement at more than 10cm from anal margin

8. Occurrence of any of the following during the colorectal surgery:

1. Blood loss (>750 cc)

2. Blood transfusion

3. Any new sign of ischemia

4. Positive air leak test - requiring re intervention on the anastomosis

5. Inadequate bowel preparation

6. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SafeHeal Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérémie Lefevre

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Antoine Paris

Locations

UZA

Antwerp, , Belgium

Centre Hospitalier Universitaire St Pierre

Brussels, , Belgium

CHU Lille

Lille, , France

ICM Montpellier

Montpellier, , France

Hôpital Saint Louis

Paris, , France

Hôpital Saint Antoine Paris

Paris, , France

CHRU Strasbourg

Strasbourg, , France

Countries

Belgium; France

References

De Hous N, D'Urso A, Cadiere GB, Cadiere B, Rouanet P, Komen N, Lefevre JH. Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial. Surg Endosc. 2023 Sep;37(9):7385-7392. doi: 10.1007/s00464-023-10272-x. Epub 2023 Jul 18.

Reference Type: DERIVED

PMID: 37464064 (View on PubMed)

Other Identifiers

SAFE2019

Identifier Type: -

Identifier Source: org_study_id